DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 & 14-16 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1 in line 3 a “flexible device” is claimed. In the next line of the claim that is indented from line 3 “a non-deflectable section” is recited. How can you have a “flexible device” made up of “a non-deflectable” piece? Examiner will interpret the “flexible device” as just a “device”.
Claims 4-6 & 14-16 recite the limitation "the device tip deflection" or “the deflection control”. There is insufficient antecedent basis for these limitation in the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8 & 10 (as best understood) are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shapira et al (US2025/0331936).
A system for controlling an interventional robotic system (Abstract first three sentence, fig. 1), comprising:
a. an elongated flexible device (300 in for example figures 1 & 2A), comprising:
i. a non-deflectable section in a proximal part of the device (400 & 500 in fig. 2A or 11B);
ii. a deflectable section in a distal part of the device (140 in figures 9D-H);
iii. a curve sensor (¶0479, “sensor 610 or 620” ¶0654), configured to sense a curve of the deflectable section (¶0715 “Curvature-tracking module 1006 may be configured to receive, from a sensor…outputs indicative of curvature of steering region 140 of catheter 100 (e.g. a bending output 1206)”); and
iv. steering wires to deflect the deflectable section (¶0016 last sentence, ¶0240 last sentence, ¶0529, ¶0530 last sentence); and
b. a processing module (figures 14) comprising:
v. a curve tracking module (1006); and
vi. a robot controller (1000 figures 13A & 20),
wherein the processing module is configured to:
calculate and perform steering actions (¶0574, ¶0587, ¶0606 last three sentences), according to a current calibration state (¶0586 “ FIG. 9B may represent a calibrated state”), by positioning each of the steering wires in a certain state (various states disclosed “rest state”, “calibrated state”, “loading state”, “bending state” etc.), for bringing the device to a target pose (¶0606 last two sentences);
receive curve tracking data from the curve tracking module (fig. 14 “curvature-tracking module”); and
use the received curve tracking data as feedback to the robot controller (fig. 14, 1000 & 1006) to determine a difference between a current pose of the device to the target pose of the device, and adjust the state of the steering wires to decrease the calculated difference (fig. 17, “refinement process 1420”, ¶0684 “refine an expected disposition”, ¶0701 “refinement process 1420” & “disposition refinement”).
Claim 2 Shapira discloses (figures 9A-H) the system of claim 1, wherein the steering wires are calibrated to achieve a zero-tension state, before a procedure or during a procedure (¶0157, ¶0585 “For some implementations, system 1000 may determine a precise position in which the wires have zero slack and zero tension.”, ¶0615, ¶0969).
Claim 3 (depending from claim 2) Shapira discloses the system of claim 1, wherein the steering wires are calibrated dynamically during a procedure, to achieve and maintain a static zero-tension state (¶0574, ¶0591 + ¶0594, ¶0598, ¶0969).
Claim 4 Shapira discloses the system of claim 1, wherein the robot controller performs a closed-loop control of the device tip deflection (¶0568, ¶0578 “FIGS. 9E-F show closed-loop feedback to maintain the curvature of steering region 140 under conditions in which an external force is applied”).
Claim 5 Shapira discloses the system of claim 1, wherein the robot controller uses a predictive model of deflection, to control the device tip deflection (¶0009, ¶0654 especially 1st sentence, ¶0655).
Claim 6 Shapira discloses the system of claim 1, wherein the deflection control is dynamically calibrated (¶0594 1st sentence).
Claim 7 Shapira discloses the system of claim 1, wherein the device includes at least two steering wires (¶0012 2nd sentence).
Claim 8 Shapira discloses the system of claim 1, wherein the device includes four steering wires (¶0012 2nd sentence).
Claim 10 Shapira discloses the system of claim 1, wherein the curve tracking module computes the curve by using an optical fiber sensor fixed at a distal tip of the device (fig. 2B 132b).
Claim(s) 11-18, 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shapira et al (US2025/0331936).
A method for controlling an interventional robotic system (¶0008, fig. 14 most comprehensive), comprising:
a. calculating and performing by a robot controller steering actions (¶0067), according to a current control calibration state (¶0574, ¶0591, ¶0969), by positioning each of a plurality of steering wires in a certain state (e.g.; “rest state”, “bending state”, “loading state”, “calibrated state” etc. & ¶0584, ¶0586), for bringing a device to a target pose (¶0606 last sentence);
b. receiving curve tracking data of the device from a curve tracking module (¶0654, “curvature tracking module 1006”, ¶0663); and using the received curve tracking data as feedback to the robot controller (¶0578 “FIGS. 9E-F show closed-loop feedback to maintain the curvature of steering region 140…FIG. 9G shows a state as steering region 140 is stiffened while retaining its bent curvature; ¶0665, ¶0688), to determine a difference between a current pose of the device to the target pose of the device (¶0606 last sentence), and adjust the state of the steering wires to decrease the calculated difference (¶0348 “adjusting a/the curvature”, ¶0520, ¶0530, ¶0578 & figures 9A-H, claim 125 ).
Claim 12 Shapira discloses (figures 9A-H) the system of claim 1, wherein the steering wires are calibrated to achieve a zero-tension state, before a procedure or during a procedure (¶0157, ¶0585 “For some implementations, system 1000 may determine a precise position in which the wires have zero slack and zero tension.”, ¶0615, ¶0969).
Claim 13 (depending from claim 12) Shapira discloses the system of claim 1, wherein the steering wires are calibrated dynamically during a procedure, to achieve and maintain a static zero-tension state (¶0574, ¶0591 + ¶0594, ¶0598, ¶0969).
Claim 14 Shapira discloses the system of claim 1, wherein the robot controller performs a closed-loop control of the device tip deflection (¶0568, ¶0578 “FIGS. 9E-F show closed-loop feedback to maintain the curvature of steering region 140 under conditions in which an external force is applied”).
Claim 15 Shapira discloses the system of claim 1, wherein the robot controller uses a predictive model of deflection, to control the device tip deflection (¶0009, ¶0654 especially 1st sentence, ¶0655).
Claim 16 Shapira discloses the system of claim 1, wherein the deflection control is dynamically calibrated (¶0594 1st sentence).
Claim 17 Shapira discloses the system of claim 1, wherein the device includes at least two steering wires (¶0012 2nd sentence).
Claim 18 Shapira discloses the system of claim 1, wherein the device includes four steering wires (¶0012 2nd sentence).
Claim 20 Shapira discloses the system of claim 1, wherein the curve tracking module computes the curve by using an optical fiber sensor fixed at a distal tip of the device (fig. 2B 132b).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 9 (as best understood) & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Shapira et al (US2025/0331936) in view of Barak et al (US2024/0382268).
Shapira does not disclose the 6DOF electromagnetic curve sensor.
Barak discloses a system for controlling an interventional robotic system that employs a 6DOF electromagnetic curve sensor (¶0067 especially sentence 5). At the time the invention was made it would have been well known to one of ordinary skill to upgrade the device of Shapira with a 6DOF electromagnetic curve sensor as disclosed by Barak for curve tracking. A motivation for employing this type of sensor would be to use a compact device that can both track position and orientation in 3 dimensional space using electromagnetic fields. This obviousness combination follows the framework of KSR case law rationale D; applying a known technique to a known device (method, product) ready for improvement to yield predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael C Zarroli whose telephone number is (571)272-2101. The examiner can normally be reached Monday-Friday 9-5 ET IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ramon Mercado can be reached at 5712705744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MICHAEL C. ZARROLI
Primary Examiner
Art Unit 3658B
/MICHAEL C ZARROLI/Primary Examiner, Art Unit 3658 /M.C.Z/Primary Examiner, Art Unit 3658